PMA P910001S018
- Device
- VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S018
- Product code
- LPC
- Decision date
- 2000-08-04
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR THE VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER, MODEL 110-003.
Current openFDA PMA Record#
- Device
- VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S018
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2000-08-04
- Decision code
- APPR
- Date received
- 2000-02-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER, MODEL 110-003.